StemCyte announced today (30th) that its umbilical cord blood-based therapy, RegeneCyte®, has officially been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of Long COVID. StemCyte is the first Taiwanese cell therapy company to receive this designation.
Long COVID is a serious post-infection complication of COVID-19, and currently, there is no effective treatment available worldwide. RegeneCyte® is the first umbilical cord blood cell therapy globally to be approved by the FDA for Phase II clinical trials targeting Long COVID. The RMAT designation was awarded based on data from these Phase II trials, allowing StemCyte to benefit from specialized FDA guidance, accelerating the development process, and offering opportunities for priority review and expedited approval for new indications.
Since initiating the Phase II clinical trial for RegeneCyte®, StemCyte has completed patient enrollment in the U.S. within just 8 months, with results expected to be unblinded soon. The RMAT designation not only brings hope for the treatment of Long COVID patients but also opens up opportunities for RegeneCyte® to expand into new market indications. Currently, StemCyte is planning Phase III clinical trials for RegeneCyte® based on FDA recommendations. Additionally, RegeneCyte® has made significant progress in its Biologics License Application (BLA) for indications such as hematologic disorders, immune system diseases, and congenital metabolic disorders, with final approval expected by the end of this year.
The FDA's RMAT designation is intended for products with breakthrough potential that address significant unmet medical needs. According to FDA data, as of June 2024, 279 RMAT applications have been submitted globally. Previously approved therapies under this designation include CAR-T treatments such as Kymriah®, Abecma®, and Breyanzi®. StemCyte is the first Taiwanese cell therapy company to receive this prestigious qualification.
Resource (mandarin): 永笙新藥RegeneCyte®全球首例治療長新冠症候群，獲FDA-RMAT資格認證
